Varicella zoster immune globulin (VARIZIG) administration up to 10 days after varicella exposure in pregnant women, immunocompromised participants, and infants: Varicella outcomes and safety results from a large, open-label, expanded-access program.

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2019-01

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Abstract

INTRODUCTION:Despite vaccination, there were more than 100,000 annual cases of varicella in the United States in 2013-2014. Individuals at highest risk of developing severe or complicated varicella include immunocompromised people, preterm infants, and pregnant women. Varicella zoster immune globulin (human) (VARIZIG) is recommended by the CDC for postexposure prophylaxis to prevent or attenuate varicella-zoster virus infection in high-risk individuals. Contemporary information on administration of VARIZIG is limited. METHODS:This open-label, expanded-access program provided VARIZIG to physician-identified, high-risk participants exposed to varicella. Participants included immunocompromised children/adults, infants (preterm, newborns whose mothers had varicella onset within 5 days before or 2 days after delivery, and those aged <1 year), and pregnant women. VARIZIG (125 IU/10 kg [up to 625 IU]) was administered intramuscularly, ideally within 96 hours, but up to 10 days, postexposure. Incidence of varicella rash and severity (>100 pox, pneumonia, or encephalitis) were assessed up to 42 days after administration. RESULTS:The varicella outcome population (n = 507) included 263 immunocompromised participants (32 adults, 231 children), 137 pregnant women, 105 infants, and 2 healthy adults with no history of varicella. Varicella incidence was 4.5% in immunocompromised participants, 7.3% in pregnant women, and 11.5% in infants. The incidence of varicella was similar when comparing VARIZIG administration ≤ 96 hours vs > 96 hours (up to 10 days) postexposure in the entire population (6.2% vs. 9.4%, respectively), and also in each subgroup. Of 34 participants with varicella, 5 developed > 100 pox and 1 developed pneumonia and encephalitis. There were no product-related deaths and only 1 serious adverse event (serum sickness) considered probably related to VARIZIG. CONCLUSION:Postexposure administration of VARIZIG was associated with low rates of varicella in high-risk participants, regardless of when administered within 10 days postexposure. VARIZIG was well-tolerated and safe in high-risk participants.

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10.1371/journal.pone.0217749

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Levin, Myron J, Jennifer M Duchon, Geeta K Swamy and Anne A Gershon (2019). Varicella zoster immune globulin (VARIZIG) administration up to 10 days after varicella exposure in pregnant women, immunocompromised participants, and infants: Varicella outcomes and safety results from a large, open-label, expanded-access program. PloS one, 14(7). p. e0217749. 10.1371/journal.pone.0217749 Retrieved from https://hdl.handle.net/10161/19145.

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Swamy

Geeta Krishna Swamy

Haywood Brown, MD Distinguished Professor of Women's Health

Dr. Geeta Swamy, MD, is Professor of Obstetrics and Gynecology in the Division of Maternal-Fetal Medicine, having served as the director of the Duke Perinatal Research Center and Vice Chair for Research and Faculty Development in the Department of ObGyn. She has achieved international acclaim as a clinician researcher and expert in the field of maternal immunization and perinatal infection. As a consultant to the World Health Organization, Dr. Swamy contributes her knowledge to advance international work to evaluate the immunogenicity, safety, and efficacy of vaccines in pregnant women. The American College of ObGyn has grown to be the “collective voice” for women’s health, and Dr. Swamy has been a leader within that organization for the last two decades. She currently serves as the Co-Principal Investigator for the NIH-NIAID Vaccine Treatment and Evaluation (VTEU) and CDC Clinical Immunization Safety Assessment. In addition, she has been a leader at Duke and nationally in promoting a culture of scientific integrity and transparency in research. She has been instrumental in developing and leading the School of Medicine’s research initiatives in administration, regulatory oversight, and compliance. In 2018, she became Vice Dean for Scientific Integrity in the School of Medicine and Associate Vice President for Research for Duke University. In these roles she oversees the Duke Office of Scientific Integrity (DOSI) which houses the Advancing Scientific Integrity, Services, & Training (ASIST) initiative, conflict of interest, clinical quality management, incident response in research, and research misconduct. She also oversees the Duke Office of Research Initiatives, the Duke Health IRB, Office of Research Administration (ORA), and Office of Research Contracts (ORC). 





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